Alcon 8065752917Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00380657529179), received between Apr 21, 2021 and Aug 14, 2026 — classified as 20 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (25 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 28, 2023Open, Classified

   Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

   Z-2407-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50249577 ↗
• MalfunctionMar 26, 2026Suction Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT NO VACUUM DURING THE MIDDLE OF CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24695496 ↗
• MalfunctionFeb 23, 2026Suction Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT ENCOUNTER WHITISH CONTENT AT SCULPT MODE AND UNABLE TO PHACO WELL DURING INTRAOCULAR LENS IMPLANTATION SURGERY. THE OTHER SURGERY DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT ANY IMPACT ON PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24413672 ↗
• MalfunctionFeb 16, 2026Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT SMALL METAL SHARD BROKE OFF PHACO TIP INSIDE THE EYE AND RETINAL FORCEPS USED TO REMOVE THE SHARD DURING THE INTRAOCULAR IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER OPENING NEW PACK. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342207 ↗
• MalfunctionJan 29, 2026Suction Problem

  A CUSTOMER REPORTED THAT ON THE SCULPT MODE OF CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION), THERE WAS NO SUCTION WITH TWO CASSETTES (PAKS). THE MACHINE, NEW PAK AND NEW HANDPIECE WAS CHANGED AND THE THIRD PAK WAS WORKING AND THE SURGERY COMPLETED. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206889 ↗
• MalfunctionJan 23, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE TIP END WAS NOT PROPERLY FINISHED, THIS APPEARS TO BE A MANUFACTURING DEFECT AT UNKNOWN TIMING OF SURGERY. THE PROCEDURE TYPE AND COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED EVENT OCCURRED DURING PHACOEMULSIFICATION SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161351 ↗
• MalfunctionJan 20, 2026Suction Problem; Obstruction of Flow

  A PHYSICIAN REPORTED THAT ASPIRATION COULD NOT BE PERFORMED DUE TO CLOGGING DURING A TEST OR SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24113712 ↗
• MalfunctionJan 13, 2026Material Twisted/Bent

  A PHYSICIAN REPORTED THAT TIP ANGLE WAS DIFFERENT DURING THE SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH SAME PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050978 ↗
• MalfunctionJan 13, 2026Material Twisted/Bent

  UPON FURTHER ASSESSMENT, IT WAS CONFIRMED THAT THE REPORTED MIX PRODUCT ISSUE INVOLVING THE ULTRASOUND TIP WAS ATTRIBUTABLE TO THE USE OF AN INCORRECT ITEM.

  Patient problems: Insufficient Information

  MAUDE report 24050768 ↗
• MalfunctionJan 12, 2026Material Twisted/Bent

  A PHYSICIAN REPORTED THAT PHACOEMULSIFICATION TIP BENT BEFORE THE SURGERY. THE PROCEDURAL TYPE WAS UNKNOWN. THE SURGERY COMPLETION AND REPLACEMENT DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24033687 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE MALE PATIENT EXPERIENCED ENDOPHTHALMITIS AFTER CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANTATION). THE INFECTION WAS DETECTED IN THE PRELIMINARY ANALYSES OF THE COLLECTED SAMPLE. THE PATIENT HAS GIVEN INTRAVITREAL ANTIBIOTIC INJECTION AND PPV (PARS PLANA VITRECTOMY). THE PATIENT WAS TREATED IN OTHER HOSPITAL. THE CURRENT CONDITION OF THE PATIENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE. THIS REPORT IS PERTAINING PATIENT SIX OF SIX PATIENTS REPORTED FROM THE SAME FACILITY.

  Patient problems: Endophthalmitis; Insufficient Information

  MAUDE report 23816275 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION USING THE OPHTHALMIC OPERATING SYSTEM, THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS. THE SCHEDULED CATARACT SURGERY WAS COMPLETED ON THE SAME DAY. THE PATIENT WAS TREATED WITH AN INTRAVITREAL ANTIBIOTIC INJECTION AND UNDERWENT PARS PLANA VITRECTOMY (PPV). THE PATIENT ALSO DIAGNOSED WITH RETINAL DETACHMENT AND PROLIFERATIVE VITREORETINOPATHY (PVR) AND PROBABLY REQUIRED SECONDARY PARS PLANA VITRECTOMY (PPV). ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE. THIS REPORT WAS PERTAINING TWO OF SIX PATIENTS REPORTED FROM THE SAME FACILITY. THIS REPORT PERTAINS TO CASSETTE INVOLVED IN REPORTED EVENTS.

  Patient problems: Endophthalmitis; Retinal Detachment

  MAUDE report 23787002 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION USING THE OPHTHALMIC OPERATING SYSTEM, THE FEMALE ELDERLY PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS POST SURGERY. THE SCHEDULED CATARACT SURGERY WAS COMPLETED ON THE SAME DAY. THE PATIENT WAS TREATED WITH AN INTRAVITREAL ANTIBIOTIC INJECTION. THE CURRENT HEALTH STATE WAS NOT FULLY KNOWN YET, SINCE THEY WERE TREATED IN OTHER HOSPITALS. THE FEMALE PATIENT INVOLVED IN THIS REPORT ALREADY GOT OUT OF THE HOSPITAL AND WAS DOING BETTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE. THIS REPORT IS PERTAINING THREE OF SIX PATIENTS REPORTED FROM THE SAME FACILITY. THIS REPORT ALSO PERTAINS TO CASSETTE INVOLVED IN REPORTED EVENTS.

  Patient problems: Endophthalmitis

  MAUDE report 23765512 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION USING THE OPHTHALMIC OPERATING SYSTEM, THE MALE ELDERLY PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS. THE SURGERY WAS COMPLETED ON THE SAME DAY. THE PATIENT WAS TREATED WITH AN INTRAVITREAL ANTIBIOTIC INJECTION AND UNDERWENT PARS PLANA VITRECTOMY. THE CURRENT HEALTH STATE WAS NOT FULLY KNOWN YET BUT AS PER DOCTOR, HE WAS ABLE TO READ SOME SMALL LETTERS AND THAT HE WAS MUCH BETTER THAN THE BEGINNING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE. THIS REPORT PERTAINS TO CASSETTE INVOLVED IN REPORTED EVENTS.

  Patient problems: Endophthalmitis

  MAUDE report 23739159 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION USING THE OPHTHALMIC OPERATING SYSTEM, THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS FOLLOWING DAYS. THE SCHEDULED CATARACT SURGERY WAS COMPLETED ON THE SAME DAY. THE PATIENT WAS TREATED WITH AN INTRAVITREAL ANTIBIOTIC INJECTION ON TWO DIFFERENT DAYS. THE CURRENT PATIENT¿S CONDITION WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE. THIS REPORT WAS PERTAINING FOURTH OF SIX PATIENTS REPORTED FROM THE SAME FACILITY. THIS REPORT PERTAINS TO CASSETTE INVOLVED IN REPORTED EVENTS.

  Patient problems: Endophthalmitis

  MAUDE report 23701995 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS. THE SURGERY DETAILS WERE UNKNOWN. THE PATIENT WAS TREATED WITH AN INTRAVITREAL ANTIBIOTIC INJECTION ON TWO DIFFERENT DAYS. THE CURRENT PATIENT¿S CONDITION WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE. THIS REPORT IS PERTAINING FIVE OF SIX PATIENTS REPORTED FROM THE SAME FACILITY. THIS REPORT PERTAINS TO CASSETTE INVOLVED IN THIS REPORTED EVENT.

  Patient problems: Endophthalmitis

  MAUDE report 23691738 ↗
• MalfunctionNov 28, 2025Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT SUCTION FAILURE OCCURRED DURING ULTRASOUND MODE OF CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION). THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT ANY PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23669709 ↗
• MalfunctionNov 21, 2025Material Twisted/Bent; Material Twisted/Bent

  A NURSE REPORTED THAT THE BALANCED TIP WAS CROOKED BEFORE CATARACT WITH INTRAOCULAR LENS IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23613703 ↗
• MalfunctionNov 17, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT ASPIRATION ISSUE DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569565 ↗
• MalfunctionNov 3, 2025Suction Problem; Suction Problem

  A NURSE REPORTED THAT THE VACUUM AND TORSIONAL POWER WAS NOT STRONG DURING QUADRANT REMOVAL STAGE OF CATARACT WITH INTRAOCULAR LENS IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED AND REPORTED THAT WEAK VACUUM AND TORSIONAL POWER OCCURRED DURING PHACOEMULSIFICATION AT STAGE TWO QUADRANT REMOVAL. THE CASSETTE WAS UNABLE TO CREATE VACUUM, AND AS A RESULT, THE TORSIONAL POWER COULD NOT EMULSIFY THE FRAGMENT. THE ISSUE WAS THAT THE SURGEON WAS UNABLE TO ACHIEVE FULL OCCLUSION. THERE WAS NO PROBLEM WITH THE PHACOEMULSIFICATION HANDPIECE OR THE TIP. THE SURGERY WAS COMPLETED SMOOTHLY USING A NEW CASSETTE, ALONG WITH THE SAME PHACOEMULSIFICATION HANDPIECE AND TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23449335 ↗
• MalfunctionSep 15, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT THE BLOCKAGE ALARM MESSAGE WAS DISPLAYED DURING SURGERY, AND THE PRODUCT COULD NOT BE USED. THE SURGERY WAS COMPLETED ON THE SAME DAY AND IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23059817 ↗
• MalfunctionAug 7, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  UPON FOLLOW UP INFORMATION IT WAS CONFIRMED THAT THERE WAS NO ISSUE WITH PHACO TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22736291 ↗
• MalfunctionJul 25, 2025Obstruction of Flow; Obstruction of Flow

  A NURSE REPORTED PHACOEMULSIFICATION TIP WAS BLOCKED DURING THE SCULPT MODE OF CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT) AND THERE WAS NO ASPIRATION OF OPHTHALMIC VISCOSURGICAL DEVICES (OVDS) AND BALANCED SALT SOLUTION (BSS). THE SURGERY WAS COMPLETED SMOOTHLY WITH THE SAME HANDPIECE AND THE NEW PAK WITH THE NEW PHACO TIP. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT PERTAINS TO PHACOEMULSIFICATION TIP INVOLVED IN THIS REPORTED EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22606959 ↗
• MalfunctionMay 29, 2025Break; Break

  A NURSE REPORTED TIP WAS BROKEN AT THE FRONT PORTION DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE PHACOEMULSIFICATION TIP WAS REMOVED FROM THE PATIENT¿S EYE. THE SURGERY WAS COMPLETED AFTER REPLACING THE TIP WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103322 ↗
• MalfunctionMar 21, 2025Defective Device; Defective Device

  A PHYSICIAN REPORTED THAT THE ACTUATION FAILURE OF THE VENT VALVE OCCURRED DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663780 ↗